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FDA Approves Skyrizi for Pediatric Psoriasis and Psoriatic Arthritis

FDA Approves Skyrizi for Pediatric Psoriasis and Psoriatic Arthritis

The U.S. Food and Drug Administration has authorized AbbVie’s Skyrizi for children aged six and older, marking the first time an IL-23 inhibitor has been cleared for pediatric patients. The approval covers both moderate-to-severe plaque psoriasis and active psoriatic arthritis, introducing a new 55 mg syringe to accommodate weight-based dosing requirements.

This regulatory expansion addresses a significant gap for younger patients, as roughly 20,000 children under the age of ten are diagnosed with psoriasis annually in the U.S. By introducing a 55 mg pre-filled syringe, the manufacturer aims to support precise dosing for children weighing less than 40 kg, while maintaining existing 150 mg options for those above that threshold.

Clinical support for the decision stems from the Phase 3 OptIMMize program, which evaluated both pharmacokinetic data and efficacy outcomes. According to Dr. Amy S. Paller, a study investigator at Northwestern University Feinberg School of Medicine, the treatment demonstrated meaningful improvements in skin and joint symptoms that remained consistent during long-term observation. AbbVie plans to support patient access through its existing assistance programs, which include co-pay options for commercially insured families and a no-charge supply for those who qualify under financial hardship guidelines.

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